FDA Device recall Z-0817-2014
VITROS Chemistry Products COCM Reagent
- FDA Device
- Class II
- terminated
- Published 2014-01-29
On 2014-01-29 the FDA classified a Class II recall of VITROS Chemistry Products COCM Reagent by Ortho Clinical Diagnostics, citing inaccurate quality control results.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0817-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-10-04 |
| Published | 2014-01-29 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ortho Clinical Diagnostics |
| Distribution | US |
Product
VITROS Chemistry Products COCM Reagent
Reason
Inaccurate quality control results.
Identifiers
| code_info | Product Code: 6801995; Lot numbers: 1) 1525-09-2754 Exp Date: 1 Nov 2013, 2) 1525-10-2091 Exp Date: 1 March 2014, 3) 1525-10-3062; Exp Date: 1 April 2014 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0817-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.